Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery

Cardiac Valve Replacement Complication Clinical Trial

Official title:

Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085770
• Other study ID #: CL(1686)
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: September 3, 2019

Study information

• Verified date: September 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of Vitamin D supplementation on ICU and hospital LOS in patients undergoing valve replacement surgery. Half of the patients will receive Alfacalcidol, while the other half-the control group- will be exposed to the same environment without receiving alfacalcidol.

Description:

Vitamin D insufficiency has been reported in more than 80% of critically ill patients, hospitalized in intensive care unit (ICU), including cardiac surgical patients. Moreover, 25(OH)D levels continue to decrease from baseline throughout the hospital stay and resolves by 6 months. Vitamin D levels < 20 ng/ml is associated with higher mortality, infection rates and prolonged length of ICU saty.

The discovery of vitamin D receptors (VDR) expressed on cardiac muscle and vasculature, released a strong hypothesis suggesting that vitamin D regulates RAAS activity and cardiac remodeling.

The beneficial effects of vitamin D on cardiovascular system, immune function and wound healing could be of particular interest in critical care, and patients undergoing valve replacement surgery will benefit the most.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 3, 2019
• Est. primary completion date: February 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients undergoing mechanical valve replacement surgery

Exclusion Criteria:

• combined valvular replacement surgery and Coronary Artery Bypass Graft (CABG) surgery

• valvular replacement redo

• valvular replacement surgery secondary to infective endocarditis

• on dialysis

• ALT levels 2-3 times higher than normal range

• CHD,

• impaired gastrointestinal function

• indication for vitamin D supplementation within the prior month

• hypercalcemia defined as total calcium >10.4 mg/dl

• hyperphosphatemia defined as serum phosphate > 4.5 mg/dl

• pregnancy and lactation.

Related Conditions & MeSH terms

• Cardiac Valve Replacement Complication

Intervention

Drug:
• Alfacalcidol 1 MCG Oral Capsule
2 mcg of oral Bone Care© soft gelatin capsules once daily with food starting from the day of admission till the end of hospital stay

Locations

Country	Name	City	State
Egypt	El-Demerdash Cardiac Academy Hospital, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital length of stay	length of hospital stay in days starting from ICU admission to hospital discharge.	time to hospital discharge, up to 15 days
Primary	intensive-care unite length of stay	length of hospital stay in hours starting from ICU admission to ICU discharge.	time to ICU discharge, up to 7 days
Secondary	Rate of postoperative complications	compare rate of postoperative infections, decline in LV functions, MI or massive bleeding between the 2 arms	during hospital stay, up to 15 days
Secondary	mortality	compare mortality rate between the 2 arms	during hospital stay, up to 15 days
Secondary	monitor alfacalcidol safety	the measurement of alfacalcidol blood concentration indirectly through the measurement of serum 25(OH)D and monitoring of its metabolic effect through the measurement of serum total calcium and phosphorous	during hospital stay, up tp 15 days